N.Y. Comp. Codes R. & Regs. tit. 10 § 405.17

Current through Register Vol. 46, No. 45, November 2, 2024

Section 405.17 - Pharmaceutical services

The hospital shall provide pharmaceutical services that are available at all times on the premises to meet the needs of the patients. The hospital shall have a pharmacy that is registered and operated in accordance with article 137 of the New York State Education Law and is directed by a registered pharmacist trained in the specialized functions of hospital pharmacy.

(a)Organization and direction.

The pharmacy shall be responsible, in conjunction with the medical staff, for ensuring the health and safety of patients through the organization, management and operation of the service in accordance with generally accepted professional principles and the proper selection, storage, preparation, distribution, use, control, disposal and accountability of drugs and pharmaceuticals.

(1) The director shall be employed on a full-time or part-time basis based on the needs of the hospital.

(2) The director, in conjunction with designated members of the medical staff, shall ensure that:

(i) for patients of all ages weight shall be measured in metric units. Up-to-date drug information reference systems relating to drug interactions, drug therapies, side effects, toxicology, dosage, indications for use, and routes of administration are available to the professional staff. Pediatric dosing resources shall include age and size appropriate fluid and medication administration and dosing. Pediatric dosing must be weight based, should include the calculated dose, the dosing determination, such as the dose per weight (e.g., milligrams per kilogram) or body surface area, to facilitate an independent double-check of the calculation, and should not exceed adult maximum dosage, or in emergencies, length based;

(ii) a formulary is established and reviewed at least annually and updated as necessary to meet the needs of the patients for use in the hospital to assure quality pharmaceuticals at reasonable costs;

(iii) standards are established concerning the use and control of investigational drugs and research in the use of recognized drugs;

(iv) clinical data are evaluated concerning new drugs or preparations requested for use in the hospital; and

(v) the list of floor stock medication is reviewed and recommendations are made concerning drugs to be stocked on the nursing unit floors and by other services.

(3) The director shall be responsible for developing and implementing written policies and procedures for the intrahospital distribution of drugs.

(4) Effective October 1, 1990, each hospital shall have implemented a unit-dose distribution system.

(5) The pharmaceutical service shall have an adequate number of registered pharmacists and other qualified personnel to ensure the availability of quality services including emergency services, 24 hours per day, seven days per week.

(6) All drug storage, preparation and dispensing shall be under the supervision of the director and shall be monitored for adherence to hospital policies and procedures. Monitoring reports shall be documented and available for inspection.

(7) The director shall ensure that current and accurate records are kept of the transactions of the pharmacy, including but not limited to:

(i) a system of records and bookkeeping in accordance with the policies of the hospital for:

(a) maintaining adequate control over the requisitioning and dispensing of all drugs and pharmaceutical supplies; and

(b) charging patients for drugs and pharmaceutical supplies;

(ii) a record of inventory and dispensing of all controlled substances maintained in accordance with article 33 of the Public Health Law and Part 80 of this Title; and

(iii) the labeling of all inpatient and outpatient medications in accordance with article 137 of the State Education Law and 8 NYCRR section 29.7.

(8) The director shall ensure that drug monitoring services are provided appropriate to each inpatient's needs. This shall include, but not be limited to, the maintenance of a medication record or drug profile for each inpatient which is based on available drug history and current therapy.

(9) The director will ensure that there is a quality assurance program to monitor personnel qualifications, training, performance, equipment and facilities.

(i) The director shall require and document the participation of pharmacy personnel in relevant education programs, including orientation of new employees as well as inservice and outside continuing education programs.

(ii) The quality assurance program shall include policies, procedures and monitoring and improvement activities to identify, measure, prevent, minimize and/or mitigate adverse drug events, adverse drug reactions and medication errors in accordance with generally accepted standards and practices in the field of medication safety and quality improvement.

(iii) The director in conjunction with the medical staff shall ensure the monitoring and evaluation of the quality and appropriateness of patient services provided by the pharmaceutical service.

(10) The director shall participate in those aspects of the hospital's overall quality assurance program that relate to drug utilization and effectiveness.

(b)Operation and service delivery.

All drugs and biologicals shall be controlled and distributed in accordance with written policies and procedures to maximize patient safety and quality of care.

(1) The compounding, preparation, labeling or dispensing of drugs shall be performed by a licensed pharmacist or pharmacy intern in accordance with applicable State and Federal laws, rules and regulations.

(2) All packing and repacking of medications shall be performed in the pharmacy by or under the direct supervision of a pharmacist in accordance with article 137 of the State Education Law.

(i) Written policies and procedures shall indicate how such packages shall be labeled to identify the lot number or reference code and manufacturer's or distributor's name for proper identification and safety.

(ii) Repacking and inventory records shall be maintained by the pharmacy.

(iii) Written policies and procedures shall specify those medications which will not be obtained from manufacturers or distributors in single unit packages and those which will not be repackaged as single units in the facility.

(3) Policies and procedures for the unit-dose drug distribution system shall be developed and implemented and shall include, but not be limited to:

(i) each patient shall have his or her own receptacle, such as a tray, bin, box cassette, drawer or compartment, appropriately labeled as to patient, and containing his or her own medications. Each single unit package of medication shall be labeled in accordance with requirements set forth in article 137 of the State Education Law;

(ii) delivery and exchange of patient medications shall occur as scheduled and as specified in the service's written policies and procedures. Not more than a 72-hour supply of prescribed medications shall be delivered to or available in the patient care area at any time;

(iii) methods for procuring drugs on a routine basis, in emergencies and in the event of disaster shall be identified in the service's written policies and procedures; and

(iv) written policies and procedures shall be developed and implemented regarding emergency kits and emergency carts including provisions for ensuring that emergency kits are secure and accessible and are specific to service locations, but are not kept under lock and key;

(a) locations and contents shall be identified and approved by the pharmaceutical service and the medical staff;

(b) frequency of checking contents and expiration dates shall be specified in written policies and procedures.

(4) Outdated, mislabeled, discontinued, expired or otherwise unusable drugs and biologicals shall not be available for patient use.

(5) A procedure shall be developed to provide for the availability of drugs and biologicals during periods of time when a pharmacist may not be immediately available.

(6) Drugs and biologicals not specifically prescribed as to time or number of doses shall automatically be stopped after a time that is specified in the service's policies and procedures as determined by the medical staff.

(7) Policies and procedures shall be developed and implemented for documenting, reviewing and, as appropriate, reporting dispensing errors, adverse drug reactions and drug defects.

(c)Physical facilities.

The hospital shall provide facilities for the storage, safeguarding, preparation, and dispensing of drugs.

(1) Floor stock medications shall be issued to floor units in accordance with the facility's written policies and procedures:

(i) all floor stocks must be properly controlled and shall be limited to those medications identified on an approved floor stock list;

(ii) floor stock will be checked at least monthly by or under the direct supervision of a pharmacist for outdated and unauthorized medications.

(2) All drugs and biologicals shall be stored in locked storage areas and all controlled substances shall be stored in accordance with the storage requirements set forth in article 33 of the Public Health Law and Part 80 of this Title.

(3) All abuses and losses of controlled substances shall be reported to the director, and to the medical staff, as appropriate, in accordance with applicable Federal and State laws.

N.Y. Comp. Codes R. & Regs. Tit. 10 § 405.17

Amended New York State Register November 13, 2019/Volume XLI, Issue 46, eff. 11/13/2019